Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001245280p
Ethics application status
Not yet submitted
Date submitted
16/07/2018
Date registered
24/07/2018
Date last updated
15/06/2021
Date data sharing statement initially provided
29/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Betadine Sore Throat Gargle for removal of nasal Staphylococcus aureus
Scientific title
Application of Betadine Sore Throat Gargle for nasal decolonisation of Staphylococcus aureus: a within subject randomised crossover trial
Secondary ID [1] 295471 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infection 308731 0
Prosthetic Joint Infection 308732 0
Nasal Decolonisation 308733 0
Surgical Site Infection 308734 0
Condition category
Condition code
Infection 307671 307671 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will have three treatment groups.
Group 1 - Control (for nasal application)
- 0.9% NaCl (sterile saline) - apply 1 soaked swab into each nostril for 30 seconds each, in two consecutive applications. At the end a total application time of 1 minute per nostril should be achieved. Repeat this twice a day (morning and evening), for total of 5 days.
Group 2 - Mupirocin ointment cream (Bactroban ointment for nasal application)
- Mupirocin 2% w/w active ingredient - approximately 0.5g into each nostril twice a day (morning and evening) for total of 5 days.
Group 3 - Betadine Sore Throat Gargle (nasal application)
- Povidone Iodine 7.5% w/v active ingredient - apply 1 soaked swab into each nostril for 30 seconds each, in two consecutive applications. At the end a total application time of 1 minute per nostril should be achieved. Betadine Sore Throat gargle is a single application (once only).
This is a crossover trial. A washout period of 2 weeks will be provided to each participant before commencing the next treatment.

Participants will be self administering the treatments. Participants will be provided with information of how the treatments should be applied. Compliance to treatment will be monitored by the return of used treatment vials and as part of the evaluation question at the end of treatment.
Intervention code [1] 301788 0
Treatment: Drugs
Comparator / control treatment
Control arm of this study includes nasal application of 0.9% NaCl (saline). Comparison will be made between all three groups
Control group
Placebo

Outcomes
Primary outcome [1] 306658 0
Demonstrate the concentration of S. aureus from nasal swabs following application of Betadine Sore Throat Gargle by assessing bacterial numbers from microbiological culture.
Timepoint [1] 306658 0
4 hours, 8 hours and 24 hours after application. The primary timepoint is not applicable as bacterial numbers are measured at each of these time points and compared to each other and pre treatment. The difference in bacterial numbers across all the time points will be assessed to determine the primary aim.
All three groups including control group will undergo nasal swabs at 4 hours, 8 hours and 24 hours following treatment.
Secondary outcome [1] 349166 0
Determine the number of participants with successful S.aureus eradication from nose, assessed from nasal swabs and microbiological culture.
Timepoint [1] 349166 0
24 hours following application.
Control group will undergo nasal swabs at same time points as other treatment groups. Therefore control group will have nasal swabs at 4, 8 and 24 hours post treatment
Secondary outcome [2] 349167 0
Determine the length of time the nasal application of Betadine Sore Throat Gargle can provide absolute eradication of nasal S. aureus assessed by nasal swabs and microbiological culture.
Timepoint [2] 349167 0
4, 8, 24 hours following application
Control group will undergo nasal swabs at same time points as other treatment groups. Therefore control group will have nasal swabs at 4, 8 and 24 hours post treatment.

Eligibility
Key inclusion criteria
Individuals with persistent S. aureus colonisation (3 consecutive positive nasal swabs)
Male and Female
Age 18-90
Able to provide informed consent
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals without S. aureus nasal colonisation or with intermittent colonisation (<3 consecutive positive swabs)
Individuals unable to comply with assessment and application requirements
Known hypersensitivity to iodine, povidone or mupirocin
Pregnancy
Individuals unable to provide informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation with use of computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power calculations are based on the findings of Anderson et al. (2015), where the mean S. aureus numbers recovered from the anterior nares of healthy individuals was 5.9 x 104 colony forming units (CFU). Following a single application of 3M SNP within the nostrils, bacterial numbers were significantly reduced by of 100 CFU (SD, 1.52) in SNP-treated individuals, compared to saline controls (effect size, 1.765). Assuming Type I error (alpha) to 5% (p = 0.05) and Type II error (beta) to 0.2 (power equal to 80%), and an effect size of 1.765, the sample size calculated to be able to observe a decrease in S. aureus numbers following BSTG treatment for a within-group design, is 5 participants known to be positive for S. aureus nasal carriage. To compensate for unexpected withdrawal from the study, we will include a total of 8 participants, who have been demonstrated to be persistent nasal carriers of S. aureus.
The null hypothesis of this study was that a single application of Betadine Sore Throat Gargle within the anterior nares will have no effect on nasal S. aureus colony numbers. All data will be analysed using the Statistical Sciences (SPSS, Version 22).

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
30/01/2020
Actual
Date of last participant enrolment
Anticipated
1/12/2020
Actual
Date of last data collection
Anticipated
1/08/2021
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11392 0
Mater Hospital Pimlico - Pimlico
Recruitment postcode(s) [1] 23291 0
4810 - Pimlico

Funding & Sponsors
Funding source category [1] 300062 0
Other Collaborative groups
Name [1] 300062 0
Orthopaedic Research Institute of Queensland
Country [1] 300062 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Orthopaedic Research Institute of Queensland
Address
7 Turner Street
Pimlico, QLD, 4812
Country
Australia
Secondary sponsor category [1] 299459 0
None
Name [1] 299459 0
Address [1] 299459 0
Country [1] 299459 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 300908 0
Mater Hospital and Health Services North Queensland Ltd Human Research Ethics Committee
Ethics committee address [1] 300908 0
21-37 Fulham Road, Pimlico
QLD, 4812
Australia

Ethics committee country [1] 300908 0
Australia
Date submitted for ethics approval [1] 300908 0
27/07/2018
Approval date [1] 300908 0
Ethics approval number [1] 300908 0

Summary
Brief summary
This study aims to compare the effects of Betadine Sore Throat Gargle in decolonising nasal S. aureus, as well as to quantify the decrease in S. aureus numbers and the length of time it has an effect. This will be investigated in a healthy individual population who have persistent nasal colonisation with S. aureus.
Three treatments will be compared. A control treatment with nasal application of saline. Mupirocin Nasal Ointment which is currently used for pre operative nasal decolonisation, and nasal application of Betadine Sore Throat Gargle. This is a crossover study design which means that each of the participants will receive all the three treatments.
The outcomes examined in this study include to determine the efficacy of nasal application of Betadine Sore Throat Gargle in decolonising nasal S. aureus. To quantify the decrease in colony numbers. To determine the length of time Betadine sore throat gargle has an effect, and to see if it can provide absolute removal of nasal S. aureus.
The findings of this study may help establish an alternative method of pre-operative nasal decolonisation of S. aureus.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85238 0
Dr Dr Peter McEwen
Address 85238 0
Suite 3 Level 2 Mater Medical Centre
21-37 Fulham Road,
Pimlico QLD 4812
Country 85238 0
Australia
Phone 85238 0
+617 4779 4788
Fax 85238 0
Email 85238 0
[email protected]
Contact person for public queries
Name 85239 0
Mrs Andrea Grant
Address 85239 0
ORIQL House
7 Turner Street
Pimlico
QLD, 4812
Country 85239 0
Australia
Phone 85239 0
+61 413 685 331
Fax 85239 0
Email 85239 0
[email protected]
Contact person for scientific queries
Name 85240 0
Mrs Andrea Grant
Address 85240 0
ORIQL House
7 Turner Street
Pimlico
QLD, 4812
Country 85240 0
Australia
Phone 85240 0
+61 413 685 331
Fax 85240 0
Email 85240 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We have not yet worked out a platform on which to share the data, or the appropriate data to be shared. Our research group is currently in the in the process of coming to an agreement on this.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.